AURAVENEER CEMENT


Device Classification Name

cement, dental

510(k) Number K073101
Device Name AURAVENEER CEMENT
Applicant
DENALI CORPORATION
134 old washington street
hanover, 
MA 
02339

Applicant Contact jan g stannard
Correspondent
DENALI CORPORATION
134 old washington street
hanover, 
MA 
02339

Correspodent Contact jan g stannard
Regulation Number 872.3275
Classification Product Code
EMA  
Date Received 10/16/2007
Decision Date 01/17/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No